Analysis of the Quality and Quantity of Antibiotic Prescriptions for Bacterial Respiratory Tract Superinfection in Patients Hospitalized in COVID-19 Wards

NCT04544072 | Unknown DMC

• 1 other identifier: 2020-163
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

In this prospective observational study, a quantitative and qualitative analysis of antibiotic prescriptions for presumed respiratory tract (super)infection in patients hospitalized on COVID-19 wards will be made. Drivers of antibiotic prescription for presumed respiratory tract infection in patients suspected of being infected with COVID-19 or with definite COVID-19 infections will be identified.

Conditions

SARS-CoV Infection; Antimicrobial Stewardship; Respiratory Tract Infections; Antibiotic Resistance

Keywords

respiratory tract infection; antimicrobial stewardship; SARS-CoV infection; COVID-19; Antibiotic resistance

Outcome Measures

Primary Outcomes (4)

• Total antimicrobial consumption for suspicion of secondary bacterial respiratory infections in hospitalized patients in COVID wards with a clinical or PCR-based COVID diagnosis, expressed as 'Daily defined doses/hospitalization'.

  The total antibiotic use, expressed as Daily Defined Doses (DDD) of antibiotics in grams. This will be aggregated with the amount of hospitalizations to arrive at one reported value: DDD/hospitalization (expressed as grams/hospitalization), for every antibiotic and antibiotic formulation (IV or PO) separately but also for all prescribed antibiotics in general.

  7 months

• Total antimicrobial consumption for suspicion of secondary bacterial respiratory infections in hospitalized patients in COVID wards with a clinical or PCR-based COVID diagnosis, expressed as 'Daily defined doses/1000 hospitalized patient days'.

  The total antibiotic use, expressed as Daily Defined Doses (DDD) in grams. This will be aggregated with the total amount of hospitalized patient days to arrive at one reported value: DDD/1000 hospitalization patient days (expressed as grams/1000 hospitalization days), for every antibiotic and antibiotic formulation (IV or PO) separately but also for all prescribed antibiotics in general. 1000 hospitalised patient days for every antibiotic and antibiotic formulation (IV or PO) separately but also for all prescribed antibiotics in general.

  7 months

• Total antimicrobial consumption for suspicion of secondary bacterial respiratory infections in hospitalized patients in COVID wards with a clinical or PCR-based COVID diagnosis, expressed as 'Daily doses of administration/hospitalization'.

  The total antibiotic use, expressed as Daily Doses of Administration (DDA) of antibiotics in grams. This will be aggregated with the amount of hospitalizations to arrive at one reported value: DDA/hospitalization (expressed as grams/hospitalization), for every antibiotic and antibiotic formulation (IV or PO) separately but also for all prescribed antibiotics in general.

  7 months

• Total antimicrobial consumption for suspicion of secondary bacterial respiratory infections in hospitalized patients in COVID wards, expressed as 'Daily doses of administration (DDA)/1000 hospitalized patient days'.

  The total antibiotic use, expressed as Daily Doses of Administration (DDA) in grams. This will be aggregated with the total amount of hospitalized patient days to arrive at one reported value: DDA/1000 hospitalization patient days (expressed as grams/1000 hospitalization days), for every antibiotic and antibiotic formulation (IV or PO) separately but also for all prescribed antibiotics in general.

  7 months

Secondary Outcomes (28)

• The degree of appropriateness of antimicrobial prescriptions for presumed respiratory tract (super)infection

  7 months

• The degree of appropriateness of antimicrobial prescriptions for presumed respiratory tract (super)infection, denominator 2

  7 months

• Rate of Clostridioides Difficile infections

  7 months

• Is there a significant difference in age comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

  7 months

• Is there a significant difference in weight comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

  7 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female patients fulfilling the above mentioned inclusion criteria, hospitalized on a COVID-19 ward, having signed the informed consent form (ICF) by themselves or by one of their legal representatives.

You may qualify if:

• Men and women hospitalized in one of the COVID wards (no data will be collected during a stay on the ICU department) of UZ Brussel for more than 24 hours and willing to sign the informed consent form (or signed by one of their legal representative(s) if unable).

You may not qualify if:

• patients younger than 18 years old
• patients not willing to sign the informed consent form
• patients hospitalized for a shorter duration than 24 hours on a COVID-19 ward

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Brussels, 1090, Belgium

RECRUITING

Related Publications (1)

• Van Laethem J, Wuyts S, Van Laere S, Dirkx S, Seyler L, Mertens R, Ilsen B, Lacor P, Pierard D, Allard SD. Antibiotic Prescriptions Targeting Bacterial Respiratory Infections in Admitted Patients with COVID-19: A Prospective Observational Study. Infect Dis Ther. 2021 Dec;10(4):2575-2591. doi: 10.1007/s40121-021-00535-2. Epub 2021 Sep 16.

  PMID: 34529255 DERIVED

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; Respiratory Tract Infections; COVID-19

Condition Hierarchy (Ancestors)

Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases

Study Officials

• Johan Dr Van Laethem, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johan Dr Van Laethem, MD

CONTACT

+3224779517; johan.vanlaethem@uzbrussel.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 15, 2020
• First Posted: September 10, 2020
• Study Start: May 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: March 1, 2021
• Last Updated: September 10, 2020

Record last verified: 2020-09

Locations

BE (1)